Atmos Scope User manual

ATMOS®Scope
ATMOS®Scope Basic
GA1GB.150253.0
TPA191-158-1112-01_M
2019-01 Index: 19
Operating Instructions
English

2
Content
Further information, accessories, consumables and spare
parts are available from:
ATMOS
MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Straße 16
79853 Lenzkirch
Germany
Phone [phone]
Fax: [phone]
[phone] (Service Centre)
[email protected]
www.atmosmed.de
1.0 Introduction.........................................................3
1.1 Notes on operating instructions ............................3
1.2 Intended use .........................................................4
1.3 Function ................................................................4
1.4 Explanation of pictures and symbols ....................5
1.5 Scope of supply ................................................... 5
2.0 For your safety....................................................6
2.1 Instructions for combination with
other Medical Products .........................................6
3.0 Setting up and starting up .................................7
3.1 Overview.............................................................. 7
3.2 Front view ATMOS®Scope controller ...................8
3.3 Rear view ATMOS®Scope controller ....................8
3.4 Overview cables....................................................9
3.5 Leakage tester and hose ......................................9
3.6 Assembly/First Installation ..................................10
3.6.1 Required additional devices................................10
3.6.2 Installation at the place of operation ...................10
3.7 Tests....................................................................13
4.0 Operation...........................................................14
4.1 Use/Operation.....................................................14
4.1.1 Switching on and adjusting the system...............14
4.1.2 Controllerneadjustment...................................15
4.1.3 Functions of the buttons with ATMOSoft /
ATMOS®Capture Suite.......................................16
4.2 Disassembly........................................................16
5.0 Cleaning and care.............................................17
5.1 General instructions............................................17
5.2 Manual cleaning and disinfection........................18
5.2.1 Cleaning and disinfection: Controller and
microphone .........................................................18
5.2.2 Cleaning and disinfection: ATMOS®Scope
 handlewithexibleendoscopepart....................18
5.3 Mechanical cleaning and disinfection .................20
5.4 Sterilization .........................................................21
5.4.1 General instructions............................................21
5.4.2 Sterilization methods...........................................21
6.0 Maintenance and Service.................................23
7.0 Troubleshooting................................................24
8.0 Accessories and spare parts...........................25
9.0 Technical data ...................................................27
10.0 Disposal.............................................................28
11.0 Notes on EMC....................................................29

3
1.0 Introduction
1.1 Notes on Operating Instructions
These operating instructions contain important notes on how to operate the ATMOS®Scope, correctly
and effectively. Their reading helps to avoid risks, and also to avoid repair costs and down-times. This
increases also the reliability and service-life of your device.
These operating instructions serve not only for new operating personnel to be instructed in its use, but
also for use as a reference manual. This document may only be reprinted, either in part or in whole, with
written permission from ATMOS.
These operating instructions must always be kept available near the device.
Care and period tests in conjunction with professional execution provide for operational safety and
readiness for use of your ATMOS®Scope and are therefore a must besides regular cleaning.
Repair work and period tests may be carried out only by expert personnel authorised by ATMOS. By
applying only original spare parts you will have the guarantee that operational safety, readiness for work
and the value of your ATMOS®Scope will be preserved.
• The product ATMOS®Scope bears CE marking CE according to the EC Directive of the council for
medical products 93/42/EEC and meets the basic requirements of Appendix I of the directive.
• The product ATMOS®Scope complies with all applicable requirements of the Directive 2011/65/EC
restricting the use of certain hazardous substances in electrical and electronic equipment (“RoHS”).
• The declaration of conformity and our general standard terms and conditions can be obtained on our
website at www.atmosmed.com.
• ThequalitymanagementsystemappliedatATMOShasbeencertiedaccordingtointernational
standards EN ISO 13485.
• Prior to start-up please peruse chapter 2.0 „For your safety“, in order to be prepared for any possible
dangerous situations.
These operating instructions are valid for the following
devices:
• ATMOS®Scope REF 950.0300.0
• ATMOS®Scope Basic REF 950.0330.0

4
1.2 Intended use
Name ATMOS® Scope / ATMOS® Scope Basic
Main function During an endoscopy procedure the use of the ATMOS® Scope / ATMOS® Scope
Basic is indicated for the temporary application in the oral cavity up to the throat
andinthenasalcavity.Itenablesthevisualizationofbodyoricesandbodycavi-
ties.
Medical indications/application For the endoscopic visualisation and diagnosis in the mouth and the nasal cavities
and in the upper airway anatomy and in the auditory canal with the eardrums.
Specicationofthemainfunction With the all-in-one handle solutions and with the innovative chip-on-tip technology,
the integrated camera and integrated LED light source makes endoscopy and
stroboscopy possible:
• Bright homogeneous illumination
• 1/18” CMOS image sensor with a high resolution of 328 x 250
• Optical angle 85°
• Distal outer diameter 3.8 mm
• Working length 300 mm
• Angulation angle 2 x 160°
• 100% waterproof
Application organ Nasal and oral cavities to the larynx, auditory canal to the ear drums
Application time Temporary
Area of application In clinics and practices for ENT doctors
Contraindications The use of CMOS-Video-Nasopharyngoscope is contraindicated if endoscopic
applications are contraindicated for any reason.
The product is: Active
Sterility Not sterile
Single-use product/re-sterilisation Reprocessing is possible
1.3 Function
TheexiblenasopharyngoscopewithintegratedcameraandLEDlightsourcecombinesthefollowingcomponentsinthe
handle:
• LED light source
• Microphonepre-amplierandremovablemicrophone(optional)
• Camera electronics
• Mechanics for controlling the angle
Thanks to optimised video pre-settings, camera setting and white balance are no longer required. The device automatically
switches to the desired stroboscopy mode.
The handle provides the following keys:
• Start-stop for video recording
• Single image storage is possible in connection with the ATMOSoft / ATMOS®Capture Suite
1.0 Introduction

5
1.4 Explanation of symbols
1.0 Introduction
!
!
■
●
→
Graphic symbols contained in these operating instructions
Warning; take extra care to
observe
Short cuts / symbols contained in these operating instructions
Please press where
dot indicates
Sub-numeration
Numeration
General information
Follow the arrows
Replace
Check
Please read,
important information
Move, plug... in this
direction
Engage, check
correctt
Turn, shift... in this
direction
)Important information
Symbols of ATMOS® Scope
Serial number
Order number
Manufacturing date
This product complies with the relevant
requirements of the EU Directives.
REF
SN Follow operating instructions
2nd-edition IEC 60601-1: Caution, observe
accompanying documents
3rd-Edition IEC 60601-1: Caution
Professional disposal
1.5 Scope of delivery
Prior to dispatch, the ATMOS®Scope was subjected to an extensive functional test and was carefully packed.
Nevertheless, please compare the contents of the shipment on completeness immediately upon receipt (see delivery note).
ATMOS®Scope Basic: ATMOS®Scope handle, controller, leakage tester, pressure compensation cap, BNC video cable (2 pcs),
silicone hose, power cable, BNC cinch adapter (2 pcs), USB 2.0 cable, remote cable for ATMOSoft / ATMOS®Capture Suite,
ATMOSoft / ATMOS®Capture Suite demo CD, operating instructions.
ATMOS®Scope: ATMOS®Scope handle, controller, leakage tester, pressure compensation cap, microphone, stroboscope cable,
BNC video cable (2 pcs), silicone hose, power cable, BNC cinch adapter (2 pcs), USB 2.0 cable, remote cable for ATMOSoft /
ATMOS®Capture Suite, ATMOSoft / ATMOS®Capture Suite demo CD, transport case, operating instructions.
Application part type BF acc. to EN 60601-1
Manufacturer
+158°F
+70°C
+68°F
-20°C
ROnly
Latex
Indicates the tolerable temperature
The US Federal Law restricts this product to sale
by or on the order of a physician
Indication that the product does not contain
natural rubber latex
95%
5%
106 kPa
70kPa
Indicates the tolerable air humidity
Indicates the tolerable air pressure
MR Magnetic resonance unsafe
Fuse
Sterilize prior to each use
NON
STERILE
click

6
2.0 For your safety
!
For your safety
• The product may only be used observing the guidelines
of this IFU. If instructions, warnings and precautions
are not observed, this may lead to risks and serious
consequences during use. Check and guarantee
unrestricted function, completeness and integrity of the
product and/or accessories before use.
• The system may only be operated with the delivered
cables. Make sure that all devices operated nearby
comply with the relevant EMC requirements. The
image quality could be affected by the electromagnetic
emissions of peripheral equipment (e. g. monitor, video
equipment) which is connected.
In case of extreme electromagnetic interferences, the
imagequalitymaybeinuenced(e.g.slightstripes,
colour changes on the monitor).
• Use in combination with MR
The product is MR unsafe - in areas with magnetic
resonance imaging, the product is unsafe.
• To separate the device completely from the mains power
supply, pull the plug out of the mains socket at the
external power.
• The plug cap must be removed from the plug during
storage and transport. Otherwise, under certain
circumstances, an overpressure could occur within the
connection cable and could damage the cable.
• When placing the product into the transport case, be
careful that no parts are pinched or clamped when
closing the lid. Otherwise the product could be damaged.
• Do not use the transport case for long-time storage.
• Accessories and/or peripheral devices, which are
connected to the interfaces of the product must comply
veriablytotherelevantnormativespecications(e.
g.IEC60601-1).Furthermore,allcongurationsofthe
systemstandardIEC60601-1-1havetobefullled.
• Unsterile parts – danger of infection
Parts, which are delivered unsterile, have to be
processed before use.
• Improper use and maintenance, as well as application in
deviance to its intended use may lead to risks for patient
and user or early wear and tear of the product.
• Endoscopic procedures may only be carried out by
specialists who have corresponding training, knowledge
and experience.
• The product is susceptible in regard to bending, heavy
kinking, torsion, tension or pressure load. This may
damage the optical components and thus lead to
operating failure.
• Onlyoperatetheproductwithinthespeciedoperating
temperature range.
• Image interferences, image breakdown or breakdown of
the integrated light source could lead to risks.
ªInthiscase,releasedeectionleverandcarefully
withdraw the ATMOS®Scope.
• Do not look directly into the light emission at the distal
end of the endoscope. This can lead to eye injury.
• Each light source can become warm due to absorption
and therefore damage to the biological tissue could
occur. Please make sure to reduce duration of use to a
minimum, to switch off the light source when not in use
and to check heat development if necessary.
• The ATMOS®Scope may be operated only in rooms
used for medical purposes, but not in areas subject to
explosion hazards and in oxygen rich environments.
2.1 Instructions for combination with
other medical products
• Multiplication of leakage current - risk for patients
If the product is used with electro medical devices and/
or power driven endoscopic accessories, the leakage
currents could multiplicate. Check external electrical
devices before use.
• If the product or endoscopic accessories are used with
products of different manufacturers and in combination
with medical electrical products, ensure that the BF
conditions (insulated, earth-free application part) are
fullled.
• Ensure that the corresponding interconnection conditions
are kept. Also, the relevant standard and the respective
national tolerances must be followed.

7
3.0 Setting up and starting up
3.1 Overview
1Deectionlever 7Plug
2Pressure compensation valve with dust protection cap 8Plug cap
3Microphone (optional) 9Deectabletip
4Button A 10 Tip cover glass
5Button B 11 Microphone interface
6Connection cable
Fig. 1
1
23
4
5
6
7 8
10
9
11
3

8
3.0 Setting up and starting up
3.2 Front view ATMOS®Scope controller
13 Socket for connection cable 6
14 ON/OFF switch
Fig. 2
3.3 Rear view ATMOS®Scope controller
15 BNC video outputs (composite/CVBS signal)
16 3.5 mm jack plug (Remote 1 signal)
17 3.5 mm jack plug (Remote 2 signal)
18 Plug for stroboscope cable
19 USB 2.0
20 Fuse holder with fuses
21 Mains connection
Fig. 3
13 14
17 20
15 16 18 19 21

9
3.4 Overview cables
22 BNC video cable 25 Remote cable
23 USB 2.0 cable 26 Stroboscope cable (optional)
24 Power cable
Fig. 4
3.0 Setting up and starting up
3.5 Leakage tester and hose
27 Leakage tester 29 Pressure compensation cap
28 Silicone hose 30 Pressure release valve
Fig. 5
22 23 24 25
26
27
28
29
30

10
3.6 Assembly/First Installation
3.6.1 Required additional devices
• Monitor according to the medical device directive 93/42/EEC.
3.6.2 Installation at the place of operation
Connecting the controller to the mains supply
Ensure that the correct power cable is used for the respective country.
• Connect power cable 24 with power connection 21 at the controller.
• Plug the power cable 24 into a mains socket and thus connect the system to the mains supply.
Connecting the monitor
• Connect BNC video cable 22 with the BNC video output 15 of the controller and composite/CVBS input of the monitor.
Connecting the PC (optional)
The PC has to conform to the medical device directive 93/42/EEC.
Installing the USB Driver on the PC
• Connect the ATMOS®Scope to the PC using the USB 2.0 connection cable 23.
• Install the driver from the enclosed CD
ªAfter the installation is completed the ATMOS®Scope will appear as a "USB 2820 Device" in the Device Manager.
• Remove software CD from the drive.
• Restart the PC.
PC minimum requirements depend on the used software.
• Follow instructions on the software CD.
Recommendation when using the software on a PC and the availability of a medical grade monitor:
As an alternative to directly connecting the monitor via the BNC video output (composite/CVBS signal) 15, it is recommended
to connect the medical grade monitor directly to the PC via the PC’s external VGA output. The prerequisites for this are proper
connectors on the PC and monitor, as well as the proper connection cables (not included).
!
3.0 Setting up and starting up

11
• Connect ATMOS®Strobo 21 LED with stroboscope cable 26 to the ATMOS®Scope controller: Connect plug (a) with "optional
connection for ATMOS®Strobo 21 LED and EndoStroboscope L (F-Out)" at the rear side of the Stroboscope. Connect plug
(c) with "connection for microphone" at the front side of the stroboscope. Connect plug (b) with connection for stroboscope
cable 18 at the controller of the ATMOS®Scope.
• For further details, refer to ATMOS®Strobo 21 LED operating instructions.
Connecting the ATMOS®Scope
• Connect the ATMOS®Scope handle with the controller, plugging the plug of connection cable 6into the socket for
connection cable 13.
Application with the ATMOSoft / ATMOS®Capture Suite
The ATMOSoft / ATMOS®Capture Suite has separate operating instructions.
Please note:
Read these separate operating instructions very carefully.
Fig. 15
3.0 Setting up and starting up
26
Connect stroboscope ATMOS®Strobo 21 LED (optional)
Rear side
ATMOS®Strobo 21 LED
Front view
ATMOS®Strobo 21 LED
Rear side
ATMOS®Scope control unit

12
3.7 Tests
Depending on the working distance (see technical data) the endoscopy image must be high-resolving, bright and clear.
The following test sequence must be conducted on the device before processing and immediately before application.
Testing the glass surfaces
• Visual inspection of the glass surfaces. The surfaces must be clean and smooth.
• If damages are discovered during inspection please see chapter Troubleshooting.
Leakage test
Fig. 17
3.0 Setting up and starting up
• Connect plug cap 8onto plug 7.
• Close pressure release valve 30 on the leakage tester 27.
• Remove dust protection cap from pressure compensation valve 2.
• Screw on pressure compensation cap 29 to pressure compensation valve 2.
• Connect silicone hose 28 with pressure compensation cap 29 and leakage tester 27.
• Pump up the system to a pressure of 300 mmHg.
• Wait for 30 seconds. By pressing the pressure release valve 30, drop the pressure to 160 mmHg.
• Wait 30 seconds and watch the pressure. The pressure must not drop down by more than 2 mmHg. If the pressure drops
more than 2 mmHg, then the system has a leak and needs to be serviced.
After the leakage test, remove pressure compensation cap 29. Refasten dust protection cap.
The leakage test must be performed after each application.
!
27
8
7
28
29
2
30

13
Testing the deection mechanism
• Slowlyoperatethedeectionlever 1(Fig. 1), to check the function.
• Checkiffulldeectionisachieved(seechapterTechnicalData).
Limitationsindeectioncanindicateanendoscopedefect.Toavoidseriousdamagetotheendoscope,onlyusetheendoscope
ifthedeectionworkssmoothlyandwithoutlimitation.
Risk for patients
Risk for patients due to the use of products with sharp edges or damaged surfaces.
• Do not use these products.
Damaged products
Do not use products with damaged camera chip (e. g. recognizable by image interferences), damaged glass surfaces or
stubborn deposits, which cannot be removed by cleaning.
Send damaged products to the manufacturer or authorized repair centre. Authorized repair centres can be inquired from the
manufacturer.
!
!
!
3.0 Setting up and starting up

14
4.0 Operation
4.1 Use/Operation
Handle the system very carefully, as it contains sensible optical, mechanical and electronic components. Do not bump the distal
end on hard surfaces.
Do not jolt or drop the ATMOS®Scope, protect it from shocks and impacts.
Donotbendorkinktheexibleendoscopepart,nortearorsqueezeit.Theoutercoatingandinnercomponentscouldbe
damaged.
Nevermovethetipoftheexibleendoscopeagainstaresistance.Thetipcontainsopticalcomponents,whichmayscratchor
break when used incorrectly.
4.1.1 Switching on and adjusting the system
Proper system operation cannot be guaranteed if the controller is switched on before the ATMOS®Scope handle is connected.
• Ensure, that the ATMOS®Scope is connected to the controller before switching on the system.
!
!
Fig. 17
3
11
• Plug the microphone 3into the microphone interface 11 of the ATMOS®Scope handle. Magnets inside the microphone
automatically orientate the microphone 3tofaceinthedirectionoftheexibleendoscopepart.
• Switch on controller with the ON/OFF switch 14. Switch on all additional devices.
• Switch on the monitor in the order to receive the signal from the controller.
• Thetipcanbemovedintwodirectionswiththedeectionlever 1.Pleasedonotpressthedeectionleverwithviolence.
• Switch off controller with the ON/OFF switch 14 after use.

15
4.0 Operation
4.1.2 Controller ne adjustment
Generallytheproductdoesnotneedtobecongured.Howevertheuserhastheoptiontomakeneadjustments.
• Turn the controller off by pressing the ON/OFF switch 14.
• Press and hold either button A 4or B 5and turn controller ON. The Set-up menu will appear on the monitor.
• Release button A 4or B 5.
• By pressing button A 4, the various setting options can be selected.
• By pressing button B 5the selected function can be activated.
• When all the settings are accepted, please select "exit and save" with the button A 4andconrmwithbuttonB 5.
• The settings menu is then hidden.
SET-UP menu options
"SHOW/HIDE FREQUENCY” Show or hide the stroboscopy frequency on the monitor
“STROBOFUNCTION MANUAL/ AUTO” Manual Mode: The stroboscopy function is activated by operating the foot
switch. If the stroboscope is not yet synchronized with the voice frequency,
minimal image inference may occur.
Automatic Mode: The stroboscopy function begins once the system is
synchronized with the voice frequency.
"SWITCH FUNCTIONS" Assigns different functions to buttons.
“COLOUR-SATURATION” Adjusts the colour saturation of the images in 5 steps
“FACTORY RESET” Returns the settings back to the factory values
“EXIT” Closes the menu and returns to live image without saving the settings
“SAVE AND EXIT” Saves the new settings, closes the menu and returns to the live image

16
4.2 Disassembly
• Remove the microphone from the microphone interface 11 and clean the ATMOS®Scope (see chapter Cleaning and
Disinfection).
• Disconnect connection cable 6fromthecontroller.Tightlyxplugcap 8.
Control box for connecting
the ATMOS®Scope with the
computer (USB connection)
Both cables must be plugged in
(see diagram). The Remote 1 in
the Remote 1 and Remote 2 in
Remote 2.
Button A: Remote 1
Button B Remote 2
Photo mode: Taking photo.
Video mode: Start and end recording.
Photo mode: Switch to the next storage space. This
function must be activated in the software.
Video mode: Pause and continue recording.
4.1.3 Functions of the buttons with ATMOSoft / ATMOS®Capture Suite
The ATMOSoft / ATMOS®Capture Suite has separate operating instructions.
4.0 Operation

17
5.0 Cleaning and care
5.1 General instructions
Adhere to national legal regulations, national and international standards and regulations as well as internal hygiene regulations
for reprocessing.
Reprocessing has to be carried out according to the manufacturer’s rules and instructions. Only use recommended agents and
procedures. Prior to each reprocessing a leakage test must be performed to prevent the endoscope from damage by liquids.
Mechanical processing provides better and safer results and should therefore be preferred to manual cleaning.
Successful processing of this medical product can only be ensured if processing is performed through a validated processing
procedure. The user/processor is responsible for the validation.
To prevent contamination of a loaded instrument tray during the procedure, do not put contaminated instruments back onto the
tray, but collect them separately.
Encrustedorxatedresiduesfromsurgerycanmakethecleaningprocessmoredifcultorineffective,andcancausecorrosion
of the stainless steel. To avoid this, the time interval between procedure and processing must not exceed 6 h. Furthermore do
not use any pre-cleaning temperature >45 °C or cleaning or disinfection agents (active ingredients: aldehyde, alcohol) which
couldxatetheresiduesevenfurther.
Excessive doses of neutralizers or basic detergents can cause chemical degradation and/or fading of laser inscriptions on
stainless steel surfaces.
Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the industrial water used
for cleaning, disinfecting and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of
stainlesssteelproducts.Toremovesuchresidues,theproductsmustberinsedsufcientlywithfullydesalinatedwateranddried
thoroughly.
Only use process chemicals that have been tested and approved (e.g. VAH/DGHM or FDA approval or CE mark) and which are
compatible with the product’s materials according to the chemical manufacturers’ recommendations. All process parameters
speciedbythechemical’smanufacturer,suchastemperature,concentrationandexposuretimes,mustbestrictlyobserved.
Failure to do so could result in the following problems:
• Optical deterioration of materials, e.g. fading or discolouration of titanium or aluminium surfaces. Visible surface changes
could occur for aluminium, with a pH > 8 in the application/process solution.
• Material damage, e.g. corrosion, cracks, breakage, premature aging or swelling.
Clean product directly after use.
Further detailed information for hygienically safe and gentle cleansing/reprocessing can be found under: www.a-k-i.org.
Preparation at the place of use
• If applicable, remove adapters and sealing cap (e. g. Luer Lock).
• If applicable, open valves/taps.
• Put the dry product into a closed disposal container and have it transferred to cleaning and disinfection within 6 h.

18
5.0 Cleaning and care
Cleaning/Disinfection
The product should not be cleaned and/or disinfected in an ultrasonic bath.
Conduct a leakage test before soaking the product in any liquids (see chapter Tests).
A leaking device can be damaged by ingress of liquids.
• Before cleaning, put plug cap 8onto plug 7.
• Ensure that the plug cap 8isrmlyconnectedtotheplug 7.
Only use detergents and disinfectants which are approved for the product. Observe manufacturer's instructions. Observe the
concentration, temperature, duration of use and contact time according to manufacturer's instructions.
Avoidexcessivepressureandtensionontotheexiblevideoscopecomponents.
Please clean carefully to prevent the device from damage. Hose and bendable end can be damaged by bending, twisting,
pushing or pulling. Coarse contaminations can be removed with a soft cloth or a soft brush.
Do not exceed a bending radius of 40 mm during reprocessing.
5.2 Manual cleaning and disinfection
5.2.1 Cleaning and disinfection: Controller and microphone
Controller and microphone should only be wiped off with a moist cloth. Do not immerse the controller and microphone in liquids.
• Wipe off the outer surfaces of the controller with a soft cloth, moistened with water, a mild soap solution or isopropanol.
• Stains,whicharedifculttoremove,canberemovedwithamildcleaningagentonammoniacbasis.
• Do not use scrubbing agents or dissolvers, as these may damage the coating or labels.
• Do not use wet sponges or cloths. Excessive cleaning agents could come into contact with electrical parts and could damage
the unit.
• Only reconnect the system to the mains supply when all cleaned parts are completely dry.
5.2.2 Cleaning and disinfection: ATMOS® Scope handle with exible endoscope part
Manual cleaning with Tristel Wipes System
Please follow the manufacturer's information and operating instructions.
Inspect visible surfaces for residual contamination after manual cleaning/disinfection. Repeat the cleaning process if necessary.
Optical surfaces should not be cleaned with a brush. Remove residues on optical surfaces with a pad moistened with alcohol
(70 % ethanol) or neutral cleaning agent.
Manual cleaning with immersion disinfection and cleaning with a brush
Phase Step T (°C/°F) t (min) Conc. (%) Water quality Chemistry
I Cleaning 34-45/
95-113 3 0.8 D-W Enzymatic cleaning agent,
e.g. Cidezyme/Enzol
II Intermediate
rinsing RT (cold) 3 x 1 --- D-W ---
III Disinfection 20-25/
68-77 12 --- D-W
0.55 %
orthophtalaldehyde
solution, e.g. Cidex OPA
IV Final rinsing RT (cold) 3 x 2 --- VE-W
sterile ---
V Drying RT --- --- --- ---
D-W Drinking water
RT Room temperature
VE-W Puriedwater(demineralized,lowgerms,maximum10germs/mlandendotoxin-poor,maximum0.25endotoxinunits/ml)
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Stage I
• Fully immerse the product in the cleaning solution. Ensure that all accessible surfaces are moistened.
• Clean the product while it is in the cleaning solution, using a soft cloth or a suitable cleaning brush, until all visible residues
have been removed from the surfaces.
• Brush all surfaces which are not accessible to visual inspection, such as hidden crevices, lumens or complex geometry for at
least1minuteuntilnomoreresiduescanberemoved.Duringcleaningmobilizenon-xedcomponents,suchassetscrews,
joints, lever etc. 3 times in each direction as far as possible.
• Thoroughly rinse these components with the cleaning solution (at least 5 times), using a disposable syringe (20 ml).
• Do not use metal cleaning brushes or other abrasives which could damage the product surfaces and could cause corrosion.
Stage II
• Thoroughlyrinsetheproduct3times(allaccessiblesurfaces)foratleast1minute.Mobilizenon-xedcomponents,suchas
set screws, joints, lever, etc. 3 times in each direction as far as possible. Use fresh water for each rinsing cycle.
• Thoroughly rinse all surfaces which are not accessible to visual inspection, such as hidden crevices, lumens (e. g. working
channel) or complex geometry with a disposable syringe (20 ml) for at least 5 times.
• Allowwatertodripoffforasufcientlengthoftime.
Stage III
• Fully immerse the product in the disinfecting solution. Ensure that all accessible surfaces are moistened.
• Mobilizenon-xedcomponents,suchassetscrews,joints,lever,etc.3timesineachdirectionasfaraspossible.
• Thoroughly rinse all surfaces which are not accessible to visual inspection, such as hidden crevices, lumens (e. g. working
channel) or complex geometry with a disposable syringe (20 ml) for at least 5 times.
Stage IV
• After disinfection the product should be thoroughly rinsed 3 times (all accessible surfaces) for at least 2 minutes. Mobilize
non-xedcomponents,suchassetscrews,joints,lever,etc.3timesineachdirectionasfaraspossible.Usefreshwaterfor
each rinsing cycle.
• Thoroughly rinse all surfaces which are not accessible to visual inspection, such as hidden crevices, lumens (e. g. working
channel) or complex geometry with a disposable syringe (20 ml) for at least 5 times.
• Allowwatertodripoffforasufcientlengthoftime.
Phase V
• Dry the product with a soft, lint-free tissue.
• Areas, which cannot be reached with the lint-free tissue, can be dried with compressed air (p max. = 0.5 bar).
Material compatibility releases exist for:
• Gigasept FF (new)
• Helipur HplusN (B. Braun Medical AG)
• Cidex OPA (Johnson & Johnson)
• Cidezyme/Enzol (Johnson & Johnson)
• Neodisher MediClean forte (Chem. Fabrik Dr. Weigert GmbH & Co. KG)
5.0 Cleaning and care

20
5.3 Mechanical cleaning and disinfection
Hints for mechanical processing
Inspect visible surfaces for residual contamination after mechanical cleaning/disinfection. Repeat the cleaning process if
necessary.
Theproductiscompatiblewithseveralautomaticexibleendoscopereprocessors(AFER).Forfurtherdetailsregardingthe
operation refer to the operating instructions of AFER.
If it is unclear whether the product and all channels can be cleaned and disinfected with the existing AFER, contact the
manufacturer of the AFER, and check with the manufacturer which cleaning and disinfection programme is suitable for the
product.
Risk of infection for patients and/or user due to
• residues of cleaning and disinfectants on the product.
• Insufcientcleaning,disinfectionandsterilizationoftheproductandaccessories.
Depending on the degree of pollution of the product especially its working channel has to be pre-cleaned or brushed.
Product damage due to excessive temperatures.
During mechanical cleaning and disinfection the temperature should not exceed 65°C.
• Position the endoscope according to the instructions of the manufacturer in the AFER.
• Connect tube of the AFER for the leakage test to the pressure compensation valve 2of the ATMOS®Scope handle. If
necessary, use adapters.
The validation that the product can be cleaned and disinfected has been conducted using the automatic endoscope
reprocessors of Wassenburg Typ WD 440 in standard programme. Thereby the cleaning agent AdaptaClean (Johnson &
Johnson) and the disinfectant Cidex OPA-C (Johnson & Johnson) have been used.
The material compatibility has been tested and guaranteed using the AFER of Wassenburg, type WD 440.
Material compatibility releases exist for:
• neodisher®MediClean forte (Dr. Weigert)
• Cidex OPA-C (Johnson & Johnson)
• AdaptaClean (Johnson & Johnson)
Colour anodized parts or plastic components (e.g. serial rings, ocular) could fade during mechanical cleaning.
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5.0 Cleaning and care